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    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH244020TE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:16.115Z</lastUpdated>
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    <udiDi>18586021479852</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH244520TE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:16.090Z</lastUpdated>
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    <udiDi>18586021479869</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH245020TE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:16.063Z</lastUpdated>
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    <udiDi>18586021479876</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-RS0330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:16.038Z</lastUpdated>
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    <udiDi>18586021479883</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-RY0330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:16.005Z</lastUpdated>
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    <udiDi>18586021479890</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-SS0330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.981Z</lastUpdated>
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    <udiDi>18586021479906</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-SY0330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.950Z</lastUpdated>
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    <udiDi>18586021479913</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-RS0360</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.923Z</lastUpdated>
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    <udiDi>18586021479920</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-RY0360</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.890Z</lastUpdated>
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    <udiDi>18586021479937</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-SS0360</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.863Z</lastUpdated>
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    <udiDi>18586021479944</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-SY0360</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.826Z</lastUpdated>
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    <udiDi>18586021479951</udiDi>
    <basicUdiDi>602147TSSETCY</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS-M10026</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.786Z</lastUpdated>
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  <row>
    <udiDi>18586021479968</udiDi>
    <basicUdiDi>602147CLSET5L</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-H20001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.748Z</lastUpdated>
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  <row>
    <udiDi>18586026080008</udiDi>
    <basicUdiDi>602147TSSETCY</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS-M04UV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.718Z</lastUpdated>
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    <udiDi>18586026080015</udiDi>
    <basicUdiDi>602147TSSETCY</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS-M05UV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.694Z</lastUpdated>
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    <udiDi>18586026080039</udiDi>
    <basicUdiDi>602147TSSETCY</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS-M07UV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.672Z</lastUpdated>
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    <udiDi>18586026080046</udiDi>
    <basicUdiDi>602147TSSETCY</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS-M08UV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.647Z</lastUpdated>
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    <udiDi>18586026080107</udiDi>
    <basicUdiDi>602147TSSETCY</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS-M10005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.626Z</lastUpdated>
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    <udiDi>18586026080114</udiDi>
    <basicUdiDi>602147TSSETCY</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS-M10006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.607Z</lastUpdated>
  </row>
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    <udiDi>18586026080121</udiDi>
    <basicUdiDi>602147TSSETCY</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TS-M10007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:15.585Z</lastUpdated>
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